Integrated Surgical Cutting System

ABSTRACT

Integrated surgical systems and methods for using same are provided that can receive scanned images and produce a three dimensional model from the images. Based at least in pan on the three dimensional model, a processor generates code defining an optimized tool path, which is sent to a surgical machining system that can machine the desired portion of the patient. In one exemplary aspect, the integrated system operates in a clearly defined and pre-programmed manner with no necessity for in-situ sensory or guidance feedback.

FIELD OF THE INVENTION

This invention relates generally to computer controlled systems for usein surgical applications involving machining of bone, other tissue,and/or other anatomical structures and methods for using same. Morespecifically, aspects of the invention relate to a robust, yet simplecomputer numerical controlled (CNC) surgical cutting system interfacedwith three dimensional medical image data.

BACKGROUND OF THE INVENTION

Automation in the field of surgical treatments has been a growing fieldin the past decade. Medical robots are being developed to assist withsome surgeries, however, known robot systems are extremely expensive andgenerally cost upwards of $750,000.

Despite the advances in medical robotics, many surgical procedurescontinue to be performed manually by surgeons and are therefore moretime consuming, which is both more expensive, and more susceptible tohuman error. For example, certain neurosurgeries require a surgeon toaccess the brain through the temporal bone. Machining an adequateopening through the temporal bone is currently performed manually. Dueto the criticality of brain and brain tumor surgeries, it will beappreciated that even a minor mistake on the part of the surgeon canresult in severe consequences. The surgical procedure generally entailsa craniotomy (removal of bone flap) and machining through the temporalbone. In one example, a channel or hole is created in the temporal boneto access the brain. Surgeons often use pneumatic hand drills at veryhigh rotational speeds to perform the surgery. The surgeon must rely onthe information he has from any preoperative images that were taken(such as CT scans) to perform the machining. Thus, the process is highlysusceptible to human error.

Furthermore, such temporal bone procedures usually take a long time(three to four hours) to simply drill the hole in the temporal bone. Theexpense of the surgeon performing the machining for several hours addsto the already high cost of these surgeries. Additionally, having thelesion open for such long time periods makes the patient susceptible toinfections that may further complicate health issues.

Thus, there is a need in the art for automated systems and methods forassisting in neurological surgeries and other surgeries that involvemachining through bone, tissue, and/or other desired anatomicalstructures that reduce the overall duration of the surgeries, minimizehuman error, and minimize overall cost of the surgeries.

SUMMARY OF THE INVENTION

In accordance with the purpose(s) of this invention, as embodied andbroadly described herein, this invention, in one aspect, relates tointegrated surgical systems and methods for using same. In one aspect,the integrated surgical system comprises a scanning or imaging devicefor scanning and/or imaging a targeted portion of a patient, such as,for example and without limitation, a patient's skull for the productionof two-dimensional (2D) images of the targeted portion. The 2D imagesare transmitted to a processor that is configured to generate athree-dimensional (3D) model from the received 2D images. In anotheraspect, a physician or surgeon can use the integrated system software todefine a location on the targeted portion of the patient to be machinedand can define the parameters of the machined hole, feature(s) orsurface(s) (such as the axis, radius, and depth). The processorgenerates code that defines an optimized tool path based on thesurgeon's input. In a further aspect, the optimized tool path can besent to a surgical machining system that is configured to machine thehole into the targeted portion of the patient. In yet another aspect,the surgical machining system is configured to allow the machining toolof the surgical machining system to operate within a simple, yet robustfive-degree of freedom operating environment, which allows the hole orfinished surface to be machined at any angle and any position as definedby the surgeon.

In one aspect, the integrated surgical system can comprise a surgicalmachining system and an imaging device for producing two-dimensionalmedical image data. In another aspect, the integrated surgical systemcan then translate this two-dimensional medical image data into athree-dimensional medical model that can then be programmed for surgeryby a surgical specialist or other user using an interactive graphicaluser interface (GUI). In operation, in yet another aspect, the surgicalspecialist or other user registers the patient with respect to theintegrated system, such that the surgical CNC machining system can thenmachine a hole as directed by the surgical specialist or other user viainputs into the system. In a further aspect, it is contemplated that thesurgical machining system can be interfaced with an interactive softwarethat controls the surgical cutting system.

In one aspect, the surgical machining system can comprise a contactcutting tool such as, for example and without limitation, abio-compatible end-mill, and the like. In another aspect, the surgicalmachining system can comprise a non-contact tool such as a laser. Ofcourse it is contemplated that the surgical machining system can beoperably coupled to any desired surgical tool for subsequent operationalong the generated optimized machine tool path.

Additional advantages of the invention will be set forth in part in thedescription which follows, and in part will be obvious from thedescription, or may be learned by practice of the invention. Theadvantages of the invention will be realized and attained by means ofthe elements and combinations particularly pointed out in the appendedclaims. It is to be understood that both the foregoing generaldescription and the following detailed description are exemplary andexplanatory only and are not restrictive of the invention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate several aspects of the inventionand together with the description, serve to explain the principles ofthe invention.

FIG. 1A illustrates an exemplary computing device, according to oneaspect of the present invention.

FIG. 1B illustrates an exemplary processing system, according to anotheraspect of the present invention.

FIG. 2A illustrates an exemplary computer numerical controlled (CNC)system for neurosurgery, according to one aspect of the presentinvention.

FIG. 2B illustrates the surgical arm and machining tool of FIG. 2A,according to a further aspect of the present invention.

FIG. 3 illustrates an exemplary embodiment of the surgical machiningsystem having a machining tool, according to another aspect of thepresent invention.

FIG. 4 is a wireframe model of a base portion of a surgical machiningsystem, according to another aspect of the present invention.

FIG. 5 illustrates an interfacing plate of a surgical machining system,according to one aspect of the present invention.

FIG. 6 is a front elevational view of a mounting member of a surgicalmachining system, according to another aspect of the present invention.

FIG. 7 is a flowchart illustrating a method for using an exemplary CNCsystem for neurosurgery according to another aspect of the presentinvention.

FIG. 8 is an exemplary screenshot illustrating CT/MRI data loaded intopre-operative planning software, according to one aspect of the presentinvention.

FIG. 9 is an exemplary screenshot of pre-operative planning softwareillustrating the function of browsing through slices of the CT/MRI dataloaded into the software, according to yet another aspect of the presentinvention.

FIG. 10 is an exemplary screenshot of pre-operative planning softwareillustrating the function of zooming in to a slice of CT/MRI data loadedinto the software, according to another aspect of the present invention.

FIG. 11 is an exemplary screenshot of pre-operative planning softwareillustrating the function of zooming out of a slice of CT/MRI dataloaded into the software, according to another aspect of the presentinvention.

FIG. 12 is an exemplary screenshot of pre-operative planning softwareillustrating the function of axis definition, according to yet anotheraspect of the present invention.

FIG. 13 is an exemplary screenshot of pre-operative planning softwareillustrating the function of dimensioning a hole to be machined,according to a further aspect of the present invention.

FIG. 14 is an exemplary screenshot of pre-operative planning softwareillustrating the function of positioning the hole to be machined of FIG.13, according to another aspect of the present invention.

FIG. 15 is an exemplary screenshot of pre-operative planning softwareillustrating the function of verifying the position of the hole to bemachined of FIG. 13, according to another aspect of the presentinvention.

FIG. 16 is an exemplary screenshot of pre-operative planning softwareillustrating the function of defining a step hole extending from themachined hole of FIG. 13, according to a further aspect of the presentinvention.

FIG. 17 is an exemplary screenshot of pre-operative planning softwareillustrating the function of positioning the step hole of FIG. 16,according to another aspect of the present invention.

FIG. 18 is an exemplary screenshot of pre-operative planning softwareillustrating fields for entry of various information to generate CNCcode, according to another aspect of the present invention.

FIG. 19 shows a model of a skull having a hole machined therein byexemplary systems of the present invention.

FIG. 20 is a schematic diagram of a method for using an exemplary CNCsystem for surgery according to another aspect of the present invention.

FIG. 21 is a graphical illustration of an exemplary tool path, accordingto one aspect of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention may be understood more readily by reference to thefollowing detailed description, examples, drawings, and claims, andtheir previous and following description. However, before the presentdevices, systems, and/or methods are disclosed and described, it is tobe understood that this invention is not limited to the specificdevices, systems, and/or methods disclosed unless otherwise specified,as such can, of course, vary. It is also to be understood that theterminology used herein is for the purpose of describing particularaspects only and is not intended to be limiting.

As used in the specification and the appended claims, the singular forms“a,” “an” and “the” include plural referents unless the context clearlydictates otherwise. Thus, for example, reference to a “machining tool”can include two or more such machining tools unless the contextindicates otherwise.

Ranges may be expressed herein as from “about” one particular value,and/or to “about” another particular value. When such a range isexpressed, another embodiment includes from the one particular valueand/or to the other particular value. Similarly, when values areexpressed as approximations, by use of the antecedent “about,” it willbe understood that the particular value forms another embodiment. Itwill be further understood that the endpoints of each of the ranges aresignificant both in relation to the other endpoint, and independently ofthe other endpoint.

As used herein, the terms “optional” or “optionally” mean that thesubsequently described event or circumstance may or may not occur, andthat the description includes instances where said event or circumstanceoccurs and instances where it does not.

Reference will now be made in detail to the present preferred aspect(s)of the invention, examples of which are illustrated in the accompanyingdrawings. Wherever possible, the same reference numbers are usedthroughout the drawings to refer to the same or like parts.

As used herein, the term “region” with respect to a patient, mayinclude, but is not limited to including, any general and/or specificportion of the patient, whether such portion be a single point on thepatient or a general area of the patient that includes a plurality ofsingle points. As used herein, the terms “property” and “properties” mayinclude, but are not limited to including, any physical or structuralproperties of the patient and/or a region(s) thereof such as, but notlimited to, a size, a shape, a location, and/or an orientation. Ofcourse, it is contemplated that other properties not described hereinmay be included within the meaning of the terms “property” and“properties” as used herein.

As may be appreciated by one skilled in the art, aspects of the presentinvention may be implemented as a method, a system, or a computerprogram product or any combination thereof. Accordingly, aspects maytake the form of an entirely hardware embodiment, an entirely softwareembodiment, or an embodiment combining software and hardware aspects.Furthermore, implementations of various aspects may take the form of acomputer program product on a computer-readable storage medium havingcomputer-readable program instructions (e.g., computer software)embodied in the storage medium. More particularly, implementations ofthe preferred embodiments may take the form of web-implemented computersoftware. Any suitable computer-readable storage medium may be utilizedincluding hard disks, CD-ROMs, optical storage devices, or magneticstorage devices.

Various aspects of the present invention are described below withreference to block diagrams and flowchart illustrations of methods,apparatuses (i.e., systems) and computer program products. It will beunderstood that each block of the block diagrams and flowchartillustrations, and combinations of blocks in the block diagrams andflowchart illustrations, respectively, can be implemented by computerprogram instructions. These computer program instructions may be loadedonto a general purpose computer, special purpose computer, or otherprogrammable data processing apparatus to produce a machine, such thatthe instructions which execute on the computer or other programmabledata processing apparatus create a means for implementing the functionsspecified in the flowchart block or blocks.

These computer program instructions may also be stored in acomputer-readable memory that can direct a computer or otherprogrammable data processing apparatus to function in a particularmanner, such that the instructions stored in the computer-readablememory produce an article of manufacture including computer-readableinstructions for implementing the function specified in the flowchartblock or blocks. The computer program instructions may also be loadedonto a computer or other programmable data processing apparatus to causea series of operational steps to be performed on the computer or otherprogrammable apparatus to produce a computer-implemented process suchthat the instructions that execute on the computer or other programmableapparatus provide steps for implementing the functions specified in theflowchart block or blocks.

Accordingly, blocks of the block diagrams and flowchart illustrationssupport combinations of means for performing the specified functions,combinations of steps for performing the specified functions and programinstruction means for performing the specified functions. It will alsobe understood that each block of the block diagrams and flowchartillustrations, and combinations of blocks in the block diagrams andflowchart illustrations, can be implemented by special purposehardware-based computer systems that perform the specified functions orsteps, or combinations of special purpose hardware and computerinstructions.

In the various aspects referenced herein, a “computer” or “computingdevice” may be referenced. Such computer may be, for example, amainframe, desktop, notebook or laptop, a hand held device such as adata acquisition and storage device, or other such device. In someinstances the computer may be a “dumb” terminal used to access data orprocessors over a network. Turning to FIG. 1A, one embodiment of acomputing device is illustrated that can be used to practice aspects ofthe preferred embodiment. In FIG. 1A, a processor 1, such as amicroprocessor, is used to execute software instructions for carryingout the defined steps. The processor receives power from a power supply17 that also provides power to the other components as necessary. Theprocessor 1 communicates using a data bus 5 that is typically 16 or 32bits wide (e.g., in parallel). The data bus 5 is used to convey data andprogram instructions, typically, between the processor and memory. Inthe present embodiment, memory can be considered primary memory 2 thatis RAM or other forms which retain the contents only during operation,or it may be non-volatile 3, such as ROM, EPROM, EEPROM, FLASH, or othertypes of memory that retain the memory contents at all times. The memorycould also be secondary memory 4, such as disk storage, that storeslarge amount of data. In some aspects, the disk storage may communicatewith the processor using an I/O bus 6 instead or a dedicated bus (notshown). The secondary memory may be a floppy disk, hard disk, compactdisk, DVD, or any other type of mass storage type known to those skilledin the computer arts.

The processor 1 also communicates with various peripherals or externaldevices using an I/O bus 6. A peripheral I/O controller 7 can be used toprovide standard interfaces, such as RS-232, RS422, DIN, USB, or otherinterfaces as appropriate to interface various input/output devices.Typical input/output devices include local printers 18, a monitor 8, akeyboard 9, and a mouse 10 or other typical pointing devices (e.g.,rollerball, trackpad, joystick, etc.).

The processor 1 typically also communicates using a communications I/Ocontroller 11 with external communication networks, and may use avariety of interfaces such as data communication oriented protocols 12such as X.25, ISDN, DSL, cable modems, etc. The communicationscontroller 11 may also incorporate a modem (not shown) for interfacingand communicating with a standard telephone line 13. Finally, thecommunications I/O controller may incorporate an Ethernet interface 14for communicating over a LAN. Any of these interfaces may be used toaccess a wide area network such as the Internet, intranets, LANs, orother data communication facilities.

Finally, the processor 1 may communicate with a wireless interface 16that is operatively connected to an antenna 15 for communicatingwirelessly with another device, using for example, and not meant belimiting, one of the IEEE 802.11 protocols, 802.15.4 protocol, or astandard 3G wireless telecommunications protocols, such as CDMA2000 1xEV-DO, GPRS, W-CDMA, or other protocol.

An alternative embodiment of a processing system that may be used isshown in FIG. 1B. In this embodiment, a distributed communication andprocessing architecture is shown involving a server 20 communicatingwith either a local client computer 26 a or a remote client computer 26b. The server 20 typically comprises a processor 21 that communicateswith a database 22, which can be viewed as a form of secondary memory,as well as primary memory 24. The processor also communicates withexternal devices using an I/O controller 23 that typically interfaceswith a LAN 25. The LAN may provide local connectivity to a networkedprinter 28 and the local client computer 26 a. These may be located inthe same facility as the server, though not necessarily in the sameroom. Communication with remote devices typically is accomplished byrouting data from the LAN 25 over a communications facility to a widearea network 27, such as the Internet. A remote client computer 26 b mayexecute a web browser, so that the remote client 26 b may interact withthe server as required by transmitted data through the wide area network27, over the LAN 25, and to the server 20.

Those skilled in the art of data networking will realize that many otheralternatives and architectures are possible and can be used to practicethe preferred embodiments. It is of course contemplated that theexemplary embodiments illustrated in FIGS. 1A and 1B can be modified indifferent ways and be within the scope of the present invention asclaimed.

Referring now to FIGS. 2A and 2B, a schematic embodiment of anintegrated surgical system 100 is illustrated. In one embodiment, and inoptional aspects, it is contemplated that the integrated surgical system100 can be portable, easily accessible and simple for a surgicalspecialist or other user to use, and does not depend on continuousvisual or other sensory feedback during the procedure (i.e., in oneaspect, the surgical path and procedure can be pre-programmed based onthe substantially fixed location and geometry of the tissue that needsto be machined). In another aspect, the integrated surgical cuttingsystem can comprise a passive imaging system that allows a surgicalspecialist or other user to view a 2D and a 3D image of an area on apatient to be operated on and to preplan a desired or optimum machinetool path for reaching the targeted area or portion.

The exemplary integrated surgical system 100 can be configured formachining a desired portion of the patient, such as, but not limited to,substantially spatially fixed tissue and/or non-spatially fixed tissue.As described herein, the integrated surgical system 100 generallyincludes an imaging device used to image at least one property of thepatient and a processor operatively connected to the imaging device forreceiving images, such as, for example and not meant to be limiting, 2Dimages produced by the imaging device of the at least one property ofthe patient. Generally, and as will be described in more detail below,in one embodiment, the integrated surgical system 100 is operable todetermine an actual 3D model of the property of a region of the patient.Moreover, integrated surgical system 100 is also operable to determine apath of a machining tool 120 that is electronically stored in a memoryassociated with, and operatively connected to, the integrated surgicalsystem.

For example, to assist surgical procedures that fabricate a tooledopening in the selected tissue of the patient, a 3D model of an expectedgeometry of the component can be generated by the processor. Optionally,the 3D model can comprise the geometry of the surfaces of the desiredportion of the patient and/or the finished surfaces that may be machinedduring the machining process. In one aspect, to fabricate one or morefinished surfaces therein the desired portion of the patient, a machinepath of the machining tool 120 can be generated based on the generatedgeometry of the 3D model, and more specifically based on the geometry ofthe desired finished portion on the patient.

In one aspect, the integrated surgical system 100 can be portable. Dueto the portability of the integrated surgical system, it is contemplatedthat the integrated surgical system 100 can be moved around a hospitaleffectively without having to resort to large infrastructure changes tothe hospital and/or operating rooms in order to accommodate theintegrated surgical system.

In one embodiment, it is contemplated that the integrated surgicalsystem 100 can update the path of the machining tool 120 based on actualproperties of the regions of the patient being machined, and morespecifically based on detected differences between the actual propertiesof the particular region being machined and the expected properties ofthe previously generated 3D model.

In one exemplary embodiment, the processor is configured to generate themodel of expected geometry of the desired portion of the patient and togenerate the desired or optimum machine path of the machining tool 120based on the geometry of the generated 3D model. In a further aspect,for example, the processor associated with, and operatively connectedto, the machining tool 120 controls operation of the machining tool andgenerates the machine path of the machining tool based on the previouslygenerated 3D geometry of the model. It is contemplated that the memorycan be associated with the machining tool 120, for example as a part ofthe machine including the machining tool. However, it is alsocontemplated that the memory can be associated with processor and/or theimaging device.

In one exemplary aspect, the desired fabricating path of the machiningtool 120 is electronically stored in memory and is executable by theprocessor. In one embodiment, the machining tool is coupled to aComputer Numerical Control (CNC) machine and the path of the machiningtool 120 is a computer numerical control path executed by the processor,which, for example, may control operation of at least a portion of theCNC machine. The processor may be operatively connected to memory foraccessing and updating the path of the machining tool 120 storedtherein. It should be understood that any number of processors may beused to perform any or all operations of the integrated surgical system100 generally that are described and/or illustrated herein. Optionally,it is contemplated that, in one embodiment, one or more processor(s)that perform any of the operations described and/or illustrated hereinwith respect to the illustrated processors may be a part of the surgicalmachining system that machines the portion of the patient (e.g., a CNCmachine), may be a part of a imaging device that images the desiredportion of the patient (e.g., the imaging device and associatedcomponents thereof), and/or may be a processor dedicated to theintegrated surgical system 100 and operatively connected to the surgicalmachining system and/or the imaging device.

In one aspect, the integrated surgical system 100 is provided thatcomprises a surgical machining system 110 and a computing device that isconfigured to at least partially control the surgical machining system.As shown in FIG. 2A, the surgical machining system 110 can comprise abase portion 112 and a support frame 122 configured to position the baseportion at a spaced distance from the floor or ground surface in theoperating environment. As one will appreciated, it is contemplated thatthe support frame can be conventionally configured, such as, for exampleand without limitation, locking wheel castors and the like, to allow forboth portability and selective fixation of the surgical machining systemrelative to the patient.

In another aspect, the surgical machining system can further comprise abridge portion 114 that extends upwardly from the base portion. Asurgical arm 118 having a proximal end and an opposed distal end can beattached to the bridge portion at its proximal end. In a further aspect,such as shown in FIG. 3, a mounting member 116 can be mounted on thebridge portion 114 and the surgical arm can extend outwardly from themounting member. The machining tool 120 can be operably positioned atthe distal end of the surgical arm.

As illustrated further in FIG. 3, in one aspect, the base portion can beconfigured as a three-axis moving gantry system. For example, the entirebase portion can move forward and backwards on the support frame 122along the Y-axis (represented by the arrow “Y”), thereby moving thesurgical arm and machining tool closer to or further from the patient150. The mounting member 116 can move from side to side on the bridgeportion 114 along the X-axis (represented by the arrow “X”). ”).According to a further aspect, the mounting member is configured to alsomove up and down along the Z-axis (represented by the arrow “Z”). Theproximal end of the surgical arm 118 can be welded or otherwise attachedto an interfacing plate 124 that is configured to move up and down themounting member 116 along the Z-axis.

In one aspect, the cooperative three-axis movement of the base portionand the mounting member (in the X, Y, and Z directions) allows thesurgical arm to be moved within a three-dimensional space without movingthe support frame 122. Additionally, the machining tool 120 can bemoved, either under machine control or manually, about two additionalaxes, θ and Φ, as shown in FIG. 2B. In another aspect, the machiningtool can be moved about the θ and/or Φ axes within a range of +/− about20 degrees. Therefore, it is contemplated that the machining tool can bemanipulated and positioned through a five-degree of freedom operatingenvironment, thereby allowing it to access the patient at any desiredangle relative to the point of interest on the patient. Additionally, inanother aspect, the five-degree of freedom operating environment iscapable of achieving advantageous access for the surgical procedurewithout having to rely on a complex robotic system, which enables themachining tool to be position effectively for performing surgery withoutunnecessary and/or convoluted positioning of the patient.

FIG. 4 illustrates a wireframe model of one aspect of a base portion 112of a surgical machining system. In this aspect, the base portion cancomprise two opposing troughs that are substantially parallel to theY-axis. The bridge portion can comprise leg members that are configuredto be slideably received within the troughs of the base portion, therebyallowing the bridge portion to move forwards and backwards along theY-axis, as described above with respect to FIG. 3.

As described above, the surgical arm 118 can extend outwardly from thebase portion (i.e., from the bridge portion, the mounting member, and/orthe interfacing plate) toward the patient. In a particular aspect, thesurgical arm can have a selected length to allow the machining tool toaccess the patient, while maintaining the rest of the surgical machiningsystem at a desired, predetermined distance from the patient. Forexample and without limitation, the length can be selected to maintainthe machining tool 120 a distance of approximately two feet from theother components of the surgical machining system. Spacing the surgicalmachining system away from the patient at a desired distance enables thesurgical machining system 110 to be used without the need to repeatedlysterilize the entire surgical machining system. For example, it iscontemplated that the surgical arm and machining tool can be configuredto be removably attached to the surgical machining system, which allowsthe surgical arm and machining tool to be sterilized prior to surgerywithout the need to sterilize the entire surgical machining system.Additionally, the offset design of the surgical arm 118 (i.e., themachining tool 120 can be offset from the bridge portion 114, the baseportion 112 and the support frame 122 by a predetermined distance) canincrease accessibility of the machining site to surgical specialistsand/or other operating room personnel.

As shown in FIG. 2B, in one aspect, the surgical arm can have asubstantially cylindrical cross-section. Optionally, the surgical armcan have a rectangular, square, or other cross-sectional shape.According to other aspects, the surgical arm can be hollow or solid. Ina particular aspect, the surgical arm can be sized and shaped to achievea desired stiffness and weight to withstand forces and vibrations duringmachining. Such an arm can be, for example and without limitation, ahollow cylindrical surgical arm such as shown in FIG. 2B. In a furtheraspect, the surgical arm can substantially comprise aluminum (such as,but not limited to, A1 6061). In yet another aspect and withoutlimitation, the hollow cylindrical surgical arm can be approximately 3.5inches in diameter, and can have a wall thickness of approximately 0.25inches, though other diameters and wall thicknesses are alsocontemplated, as will be described more fully below.

In yet another aspect, an interfacing plate 124 can be provided to whichthe proximal end of the surgical arm can be affixed. As illustrated inFIG. 5, the interfacing plate 124 can be substantially rectangular andplanar, although other geometric shapes are contemplated. In one aspect,a series of holes are defined in the plate. In a exemplary aspect,twelve holes can be formed, which, in one non-limiting example, can bepositioned in an array that is substantially parallel the periphery ofthe interfacing plate, such as shown in FIG. 5. In one exemplarynon-limiting aspect, the holes can be approximately 6 mm in diameter andcan be spaced from each other (at their centers) by a distance ofapproximately 50 mm. In a further aspect, at least one of the holes canbe configured to receive a fastener that mounts the interfacing plate toa mounting member (as exemplarily described below).

An exemplary mounting member 116 is illustrated in FIG. 6. In oneaspect, the mounting member is substantially planar and defines slotsthat extend vertically therein. For example and as shown in FIG. 6, themounting member can define four T-shaped slots. In one exemplarynon-limiting aspect, the slots can be approximately 6 mm wide and spacedfrom each other (at their centers) at approximately 50 mm. In operation,the interfacing plate 124 can be mounted to the mounting member suchthat the interfacing plate (and attached surgical arm) can be moved upand down along the Z-axis, as described above. For example, and notmeant to be limiting, at least one fastener can be used to fasten theinterfacing plate, via a hole in the interfacing plate, to acorresponding slot in the mounting member. In a further exemplaryaspect, a plurality of fasteners can be used to fasten the interfacingplate to the mounting member. For example, a fastener can be positionedwithin each of the holes of the interfacing plate 124. A correspondinghead portion of each of the fasteners can be positioned within one ofthe T-shaped slots of the mounting member, thereby fastening theinterfacing plate to the mounting member 116.

According to further aspects, the integrated surgical system 100 cancomprise at least one imaging device such as, without limitation, acomputed tomography (CT) device, a magnetic resonance imaging (MRI)device, an ultrasound device, and the like. The imaging device can beoperably connected to the computing device 130 to transmit images to theprocessor 132 of the computing device.

In one aspect, the surgical machining system can comprise a contactcutting tool such as, for example and without limitation, abio-compatible end-mill, and the like. In one exemplary aspect, themachining tool 120 can be a ¼ inch flat end mill with four flutes, oneinch cutting length and four inches of overall length. In other aspects,the tool type can be a 3/16 inch end mill or a ⅜ inch end mill. However,it is contemplated that other tools can be selected based on rigidity,diameter, length of cut, avoiding excessive overhang of the tool fromthe holder and number of flutes. As known in the arts, diamond coatedend mills can be used as they are biocompatible and are very commonlyused as surgical end mills. In another aspect, the surgical machiningsystem can comprise a non-contact tool such as a laser. Of course it iscontemplated that the surgical machining system can be operably coupledto any desired surgical tool for subsequent operation along thegenerated optimized machine tool path.

In one aspect, machining tool 120 may be any tool used in machining thedesired portion of the patient by changing a property of the desiredportion, such as, but not limited to, through removing material from thedesired portion of the patient to machine a finished surface. Althoughonly one machining tool 120 is illustrated, it should be understood thatthe integrated surgical system 100 may include and/or cooperate with anynumber of machining tools 120 to facilitate changing any number and/ortype of properties at any desired region of the patient.

Methods are provided for using the integrated surgical system asdescribed herein to automate at least a portion of neurosurgeries and/orother surgeries that involve machining through bone and/or anatomicaltissues. In one aspect, the methods described herein can be utilized tomachine through a targeted portion of the patient, such as, for exampleand without limitation, bone or tissue. In another aspect, the methodsdescribed herein can be utilized to machine through substantiallyspatially fixed and/or relatively stable bone or tissue. In stillanother aspect, it is contemplated that the methods described herein canbe utilized to machine through at least a portion of potentiallyspatially non-fixed tissue. In this aspect, for example, if a surgeondesired to remove a portion of a tumor, the methods described hereincould be used to remove a desired portion of the tumor while maintaininga desired space from the identified edges of the tumor.

According to various aspects and as described above, it is contemplatedthat the methods can be performed using a combination of the hardwarecomponents of the systems as described herein, as well as software orcomputer program product code executing on a processor of the integratedsurgical system. For convenience and clarity, the methods describedherein are described with respect to neurosurgeries involving machininginto the temporal bone of a patient's skull. It is contemplated,however, that the methods described herein can be utilized with anysurgery and are not intended to be limited to neurosurgeries.

An exemplary method begins by scanning the patient to obtain images ofthe area to be accessed by the surgical machining system during surgery.In one aspect, the patient's head can be scanned using a CT device.Optionally, the patient's head can be scanned using an MRI device. Otherdevices capable of generating images of the patient's skull can likewisebe used. According a further aspect, it is contemplated that a series oftwo-dimensional images are produced by the scanning device, such as isknown in typical CT or MRI scans.

As illustrated in FIG. 7, at step 200, the scanned images can beprovided to the processor 132 of an exemplary integrated surgical system100. At step 202, the scanned images are converted by the processor intoa solid 3-dimensional model that can be accessed in CAD software. The 3Dmodel, as well as at least one of the scanned images, can be displayedto a user via a monitor 134 or other display means of a computing device130. FIG. 8 is a screenshot of exemplary software, showing the3-dimensional model (upper left corner) formed from the scanned images,as well as “slices” or 2-dimensional images of the patient's skull. Ascan be seen, the slices show the skull from a top, side and front view.As shown in the screenshot of FIG. 9, the user of the software (such as,but not limited to, a physician, surgeon, or other medical professional)can browse through the slices to look at various portions of thepatient's skull. Likewise, as shown in FIGS. 10 and 11 respectively, theuser can zoom in or zoom out of the slices depending on the view thatthe user desires to have. As may be appreciated, the user can utilizevarious input/output devices such as described above to use thesoftware.

At step 204, the user of the software can define the region of interest(i.e., the area of the skull to be machined). As shown in the screenshotof FIG. 12, the user can first define the axis along which the machiningtool 120 is to machine. The user can then define the height and radiusof the hole to be machined (FIG. 13). As shown in FIG. 14, the user canthen set the position of the hole to be machined. As the user changesthe parameters (such as the axis, height or depth of the hole, radius ofthe hole, etc.), the visual representations of the hole within theslices and the 3D model also change (as can be seen by comparing FIGS.13 and 14). The user can then be presented with images showing the setposition and size of the hole and can verify the hole parameters (FIG.15).

In certain surgeries, it may be desirable to machine a step hole (suchas, but not limited to, a hole that extends from the initial hole, buthaving a smaller diameter than the first hole). FIG. 16 is a screenshotshowing the initial creation of a step hole, parameters of which can beset by the user (such as height and radius). As shown in FIG. 17, theposition of the step hole relative to the initial hole can also beadjusted by the user. The above-described input of the user can then beexported into a CNC code module, at step 206. The CNC code module canassist in generating the numeric control code for the surgical machiningsystem.

As illustrated in the screenshot of FIG. 18, prior to generating thenumeric control code, the user can manually enter (or accept defaultsettings) of additional parameters such as the tool type, feed rate,spindle speed, step over and step down. “Tool Type” allows a user toselect the type of tool to be used in the machining. “Feed Rate” setsthe rate at which X-axis and Y-axis motors move the components alongthese axes while the surgical machining system is in the process ofcutting. Optionally, the feed rate can be between about 1.0 and 19.0inches per minute (“ipm”), about 20.0 ipm, between about 21.0 and 31.0ipm, about 31.2 ipm and greater than 31.2 ipm. “Spindle Speed” sets therevolutions per minute of the machining tool. Optionally, the spindlespeed can be between about 1 and 8,000 rpm, about 8,000 rpm, betweenabout 8,000 rpm and 24,000 rpm, and greater than 24,000 rpm. As shown inFIG. 21, “Step Over” sets the spacing between each horizontal coil ofthe pass and “Step Down” sets the spacing between each vertical coil ofthe pass. In one aspect, default values can be obtained from calibrationof the system components or testing of the system components todetermine optimal operating conditions.

The processor, at step 208, can then generate the numeric control codefor the surgical machining system 110 and, more specifically, themachining tool 120. At step 210, the surgical machining system andmachining tool are registered in relation to the patient's head. Forexample, the patient 150 can be positioned on the operating surface 152or bed, as shown in FIG. 2A and can be fixed (i.e., restrained) in thatposition. To register the surgical machining system to the patient, itis contemplated that conventional surgical registration systems known inthe art can be used. For example, it is contemplated that the patientcan be registered to the surgical machining system 110 by using tactileposition techniques which rely on touching fiduciaries placed on thepatient, as commonly known in the arts. Once the desired portion of thepatient 150 is fixed relative to the operating surface, the registrationsystem can be used to identify the patient's orientation on theoperating surface and define the patient's coordinate system. Thesurgical machining system can then be registered to the patient'scoordinate system. In this exemplary aspect, the registration can beaccomplished by moving the tip of the machining tool 120 (i.e., thepoint of first contact with the patient) to a plurality of differentlocations, for example and without limitation, three locations, andmeasuring the coordinates of these positions in the patient coordinatesystem using the registration system.

The machining tool can then be mapped to the patient's coordinate systemusing simple geometric transforms. The transforms will report the anglebetween the surgical machining system's Z-axis and the patient'srespective Z-axis. The registration is then repeated to verify accurateadjustment of the angle of the machining tool tip. Thus, theregistration procedure is repeated until all of the transformationvalues in the registration module are zero. Using the coordinates fromthe latter set of measurements, a three-axis (αx, αy, αz) offset iscalculated between the surgical machining system coordinate system andthe patient coordinate system. Finally, the pre-calculated tool pathprogram is updated to account for this offset and a final motion plan isgenerated. At step 212, the surgical machining system 110 can beginmachining a hole in the patient's skull (e.g., the temporal bone).

An exemplary method for using an exemplary CNC system for surgeryaccording to another aspect of the present invention is illustratedschematically in FIG. 20. In one aspect, a user of the system can inputa 2D image of a patient, such as, for example and without limitation, aCT scan. A 3D image can be constructed and 2D and/or 3D images can bedisplayed on a user interface. The user interface can allow the user toselect “slices” of the patient for viewing, and the user can define theproperties of the hole to be machined into the patient. The propertiesof the hole to be machined can be exported into a CNC code module thatcan assist in creating the numeric control code for the machiningdevice. The numeric control code can be sent to the machining device,which can register the patient and execute the numeric control code.

In use, the surgical machining system 110 can machine the region ofinterest (the hole), as illustrated in FIG. 19, for example. In oneaspect, the surgical machining system can machine the region of interestas input into the system by the surgical specialist or other user atstep 204 within very close tolerances. In one aspect, the surgicalmachining system can machine the region of interest within a toleranceof +/− about 0.3200 mm. In another aspect, the surgical machining systemcan machine the region of interest within a tolerance of +/− about0.0950 mm. In still another aspect, the surgical machining system canmachine the region of interest within a tolerance of +/− about 0.0080mm.

In another embodiment, the integrated surgical system 100 can furthercomprise an active imaging system interfaced with the passive imagingsystem described above. In one aspect, an active imaging system, asknown in the arts, can be coupled to the computing device 130 and can beconfigured to transmit real-time images to the processor 132 of thecomputing device. Thus, it is contemplated that the surgical specialistcan use the passive imaging system described above to preplan a toolpath, and an active imaging system to monitor the machining process inreal time. In another aspect, the integrated surgical system 100 cancomprise a feedback loop using the active imaging system to providereal-time information about the position of the machine tool and/or thepatient. In still another aspect, it is contemplated that the integratedsurgical system can comprise a sensor or other detection means to notifythe surgical specialist based upon information from the active imagingsystem that the desired portion of the patient being operating on hasmoved relative to the surgical machining system 110. In this aspect, theintegrated surgical system can send a signal to the surgical specialistand/or the surgical machining system can turn off the machine tool.

In another embodiment, the size of the surgical machining system and/orthe machining tool 120 can be varied for different applications. Forexample, in one aspect, at least a portion of the machining tool can besized to fit into a patient's mouth for performing dental procedures. Inother aspect, the size of the surgical machining system and/or themachining tool can be varied for orthopedic and/or spinal surgeries andthe like. In still another aspect, the size of the surgical machiningsystem 110 and/or the machining tool can be sized appropriately forveterinary applications.

It will be apparent to those skilled in the art that variousmodifications and variations can be made in the present inventionwithout departing from the scope or spirit of the invention. Otheraspects of the invention will be apparent to those skilled in the artfrom consideration of the specification and practice of the inventiondisclosed herein. It is intended that the specification and examples beconsidered as exemplary only, with a true scope and spirit of theinvention being indicated by the following claims.

1. An integrated surgical system, comprising: a device for scanning aportion of a patient's body and generating a plurality oftwo-dimensional images of said portion; and a processor operativelyconnected to the device for receiving two-dimensional images therefrom,the processor configured to: generate a three-dimensional image of theportion of the patient's body from the received two-dimensional images,display the three-dimensional image, receive input from the user, theinput indicating a location of the portion to be machined during surgeryand at least one machining property, generate an optimized tool pathbased at least in part on the input, and transmit said optimized toolpath to a surgical machining system.
 2. The integrated surgical systemof claim 1, wherein the step of displaying further comprises displayingat least one of said two-dimensional images to a user.
 3. The integratedsurgical system of claim 1, wherein the surgical machining systemcomprises a variable high speed machine.
 4. The integrated surgicalsystem of claim 1, wherein the surgical machining system comprises acomputer numerical controlled surgical machining system.
 5. Theintegrated surgical system of claim 1, wherein said machining propertycomprises at least one of a shape, a size, and an orientation.
 6. Theintegrated surgical system of claim 5, wherein said machining propertyis selected from the group consisting of a machining axis, a machinehole radius, and a machine hole depth.
 7. The integrated surgical systemof claim 1, wherein said scanning device comprises a computed tomography(CT) device.
 8. The integrated surgical system of claim 1, wherein saidscanning device comprises a magnetic resonance imaging (MRI) device. 9.The integrated surgical system of claim 1, wherein the surgicalmachining system comprises a machine tool, and wherein the surgicalmachining system further comprises a means for moving the machine toolthrough a plurality of axes.
 10. A computer program product forgenerating a tool path for a machining tool used in surgery, comprising:a memory having computer readable code embodied thereon for execution bya processor, said code comprising: (a) code means for receiving aplurality of two-dimensional images of a portion of a patient's bodyfrom a scanning device; (b) code means for generating athree-dimensional image of said portion from said plurality oftwo-dimensional images; (c) code means for displaying saidthree-dimensional image and at least one of said two-dimensional imagesto a user; (d) code means for receiving input from said user, said inputindicating a location of said portion to be machined during surgery andat least one machining parameter; (e) code means for generating saidtool path based at least in part on said input; and (f) code means fortransmitting said tool path to a computer numerical controlled surgicalmachining system, wherein said computer numerical controlled surgicalmachining system comprises said machining tool.
 11. A method forautomating at least a portion of a surgery, comprising: scanning aportion of a patient's body to generate a plurality of two-dimensionalimages of said portion; transmitting said plurality of two-dimensionalimages to a processor; generating a three-dimensional image of saidportion from said plurality of two-dimensional images; displaying saidthree-dimensional image and at least one of said two-dimensional imagesto a user; receiving input from said user, said input indicating alocation of said portion to be machined during surgery and at least onemachining parameter; generating an optimized tool path based at least inpart on said input; and transmitting said optimized tool path to acomputer numerical controlled surgical machining system comprising amachining tool.
 12. The method of claim 11, further comprising machiningsaid portion of said patient's body in accordance with said optimizedtool path.
 13. The method of claim 12, further comprising registeringsaid machining tool to said portion of said patient's body, wherein saidregistering step takes place prior to said machining step.
 14. A systemfor machining a desired portion of a patient positioned on an operatingsurface, comprising: a device for scanning the desired portion of apatient's body and generating a plurality of images of said desiredportion; a processor operatively connected to the device for receivingthe images therefrom, the processor configured to: generate athree-dimensional image of the desired portion of the patient's bodyfrom the received two-dimensional images, display the three-dimensionalimage, receive input from the user, the input indicating a location ofthe desired portion to be machined during surgery and at least onemachining property, generate an optimized tool path based at least inpart on the input; a means for machining the optimized tool path in thedesired portion of the patient's body, wherein the means for machiningis in communication with the processor
 15. The system of claim 14,wherein the means for machining comprises a surgical machining system.16. The system of claim 15, wherein the surgical machining system isconfigured to be spaced a desired distance away from the operatingsurface.
 17. The system of claim 16, wherein the surgical machiningsystem is configured to be portable and movable relative to theoperating surface.
 18. The system of claim 18, wherein the surgicalmachining system comprises a machine tool.
 19. The system of claim 18,further comprising a means for moving the machine tool through aplurality of axes.
 20. The system of claim 18, wherein the machine toolis selected from a group comprising a contact cutting tool and a laser.21. The integrated surgical system of claim 15, wherein the surgicalmachining system comprises a variable high speed machine.
 22. Theintegrated surgical system of claim 15, wherein the surgical machiningsystem comprises a computer numerical controlled surgical machiningsystem.
 23. The integrated surgical system of claim 15, wherein saidmachining property of the portion comprises at least one of a shape, asize, and an orientation.
 24. The integrated surgical system of claim 23wherein said machining property is selected from the group consisting ofa machining axis, a machine hole radius, and a machine hole depth. 25.The system of claim 14, wherein the device is selected from a groupconsisting of: a computed tomography (CT) device, a magnetic resonanceimaging (MRI) device, and an ultrasound device.
 26. The system of claim14, wherein the device is configured to generate a plurality oftwo-dimensional images of said desired portion.